23 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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SYNTHES (USA) IMF SCREWS
FDA 510(k)
FDA Class 2
·Dental
Endo Carry-on Procedure Kit
FDA UDI
MEDIVATORS INC.·00677964150821·Endo Carry-on Procedure Kit contains Intercept ...
Zirlux
FDA UDI
HENRY SCHEIN, INC.·H65890105270·Zirlux Multi-Unit Abutment 5 mmH compatible wit...
FOSTER GRANT
FDA UDI
FGX INTERNATIONAL INC.·00193033163269·
FOSTER GRANT
FDA UDI
FGX INTERNATIONAL INC.·00193033163276·
FOSTER GRANT
FDA UDI
FGX INTERNATIONAL INC.·00193033163252·
FOSTER GRANT
FDA UDI
FGX INTERNATIONAL INC.·00193033163313·
FOSTER GRANT
FDA UDI
FGX INTERNATIONAL INC.·00193033163306·
FOSTER GRANT
FDA UDI
FGX INTERNATIONAL INC.·00193033163283·
FOSTER GRANT
FDA UDI
FGX INTERNATIONAL INC.·00193033163290·
Intess C
FDA UDI
Kalitec Direct LLC·B07309K0100270·Assembly, Caddie, Large Cervical Implants, Hinged
Cosmolock
FDA UDI
Kalitec Direct LLC·B07311K0100270·Tray Insert Iliac Screws 12 x 12 Assembly
Kalitec Disc Prep
FDA UDI
Kalitec Direct LLC·BO73DRK0100270·Rasp, Angled Lumbar
FOTONA FIDELIS ER: YAG LASER SYSTEM AND ACCESORIES
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
ACCUCLOT DRVVT SCREEN, CATALOG NO. A6094
FDA 510(k)
FDA Class 1
·Hematology
EON MINI
FDA Adverse Event
Injury
·ST. JUDE MEDICAL - NEUROMODULATION·Product code LGW·March 14, 2013
ZIMMER M/L TAPER MODULAR FEMORAL STEM
FDA Adverse Event
Injury
·ZIMMER INC·Product code LPH·March 1, 2011
PEDIATRIC
FDA Adverse Event
Injury
·RUSCH, INC.·Product code KOD·February 11, 2008
KYPHON KURVE BONE FILLER DEVICE 13GA
FDA Adverse Event
Malfunction
·MEDTRONIC MEXICO·Product code KIH·July 14, 2020
Upper roller bracket (part number 1088370) for the Gen2 gantry enclosure for the Radixact Treatment Delivery System.
FDA Enforcement
Class II
·Completed·Accuray Incorporated·September 6, 2023